STAINLESS STEEL SUTURE 316L
FDA 510(k) clearance K830522 · decided 1983-03-31
Clearance details
- K-number
- K830522
- Device name
- STAINLESS STEEL SUTURE 316L
- Applicant
- Sharpoint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-17
- Decision date
- 1983-03-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SILK SURGICAL SUTURES (N85143/S004) | Sharpoint, Inc. | 1988-08-31 |
| SILK SURGICAL SUTURES (N85143/S007) | Sharpoint, Inc. | 1988-07-19 |
| SILK SURGICAL SUTURES (N85143/S006) | Sharpoint, Inc. | 1988-03-22 |
| SILK SURGICAL SUTURES (N85143/S005) | Sharpoint, Inc. | 1987-10-13 |
| SUTURES (N85143/S003) | Sharpoint, Inc. | 1987-08-27 |
| SUTURES (N85143/S002) | Sharpoint, Inc. | 1987-04-03 |
| SUTURES (N85143/S001) | Sharpoint, Inc. | 1986-10-27 |